Informed Consent, Patient Safety and Navigating Stormy Seas

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“Doctor, what would you do if Sally were your child?”
Hospitals are dangerous, encumbered by system inefficiencies and human factors affecting performance. Despite all the hazards in the hospitals we do not generally ask patients to acknowledge this. Patients give consent for many aspects of care by simply agreeing to be admitted.
The concept of informed consent is part of the healthcare calculus. Informed consent may be inherently implied or formally acknowledged. For example, when patients permit clinical staff to examine them, to draw blood or obtain routine x-rays, consent is implied. No one asks patients to sign consent forms for these processes, even though they entail risks.
Signed informed consent is required for invasive procedures and for participation in clinical trials. In both circumstances there are risks that patients should acknowledge, before signing forms. Obtaining consent is tricky because doctors do not really know what patients do or do not understand, and a signature is little reassurance. Obtaining signed informed consent is coloured by many complex communication underpinnings and confounded by emotions, education, intellectual abilities, language fluency, belief systems, etc. It’s really complicated…
Case Study:
Sally is a four-year-old child recently diagnosed with acute myeloblastic leukaemia. With “standard” therapy her likelihood of cure is about 50%. The academic medical centre where she is being treated is part of a research consortium, and Sally’s doctor is encouraged to enrol patients in clinical trials. The risks of enrolment in trials are known and predictable, i.e. drug toxicities, infections, etc., and also unknown, because new combination of medications and interventions may result in untoward consequences. The benefit is the possibility, as yet unproven, of a better chance of survival.
Sally’s parents are frightened and overwhelmed and fear Sally will die without the “best therapy”.
Sally’s doctor is an oncology post-doc (trainee) working with a fully qualified oncologist. On the one hand she wants to provide care that Sally’s parents are comfortable with and that they understand. On the other hand, part of her role is to enrol patients in clinical trials; hence the conflict of interest. The doctor carefully explains the treatment options emphasizing what is known and unknown to Sally’s parents, who are tearful and clutching each other tightly. When all is said and done, and seemingly all the parents’ questions have been answered, Sally’s parents ask a crucial question. “Doctor, what do you think we should do?”
The doctor replies, “Both treatment options are reasonable. Though we hope children treated on the experimental trial may do better than those on “standard’ therapy, we do not know this for certain, and they might not do as well.”
The parents then reply with the final poignant question, “Yes Doctor, but what would you do if Sally were your child?”
Anyone uncomfortable? Are these parents capable of giving “objective” informed consent? What if one parent wants to give consent and the other does not? Do these parents truly understand the challenging issues regarding experimental therapies? If Sally is harmed by participating in the clinical trial, or her disease does not respond to therapy, will anyone be satisfied that the parents fully understood the risks? What if the parents opt for “standard” therapy and Sally dies? Has the doctor even addressed the issue of the institution’s conflict of interest for the parents? Is there anything more that the doctor can do to assist this family?
This doctor answered. “I really cannot say what I would do as, frankly speaking, Sally is not my child so I cannot truly and completely fathom the difficulty you are having in making your decision. All I can say is that both options are reasonable options, and I and all the doctors and nurses in this hospital will do everything we can to care for Sally in the best way possible. We will be with you and Sally every step of the way. We all want Sally to live.” Whew…
Obtaining informed consent is complicated. Many challenges do not present clear or ideal alternatives. Nonetheless, high reliability organizations that value communication between front line stakeholders in healthcare, i.e. doctors and patients, must navigate this issue cautiously.
Smooth sailing through potentially stormy seas; best to have a good compass in hand!


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